Senior Regulatory Specialist, Business Development - Military Veterans

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Dec 17 2024

The role of the Business Development Team is to establish and embed a fully harmonized global team supporting the execution of regulatory operational business development (BD) strategies and activities, including diligence, integration, and divestment across all modalities and taxonomies (e.g., Clinical, Nonclinical, Quality and Regulatory) enabling the delivery and support of

Regulatory Information Management (RIM). This includes:

• Enabling the execution of the various regulatory processes (including maintaining awareness of evolving external environment driving greater need for structured data)
• Ensuring the timely update of compliant data and adherence to record keeping requirements
• Delivering data quality and integrity whilst continuously seeking innovative opportunities to improve ways of working, business efficiency and drive automation

The information (data and documents) managed by Business Development is critical to patient safety, regulatory compliance and effective business operations. The post holder is accountable for the quality and accuracy of their own work and for the support of the large number of other users across GSK. Position Holder (PH) will continuously educate customers on best practice with regards to GRA systems and processes and (on a continuous basis) will feed back suggestions for improvement.

This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, these responsibilities include some of the following:

• Support the assessment of the operational capabilities of acquisition partners and manage the integration of regulatory information (data and documentation) into GSK's systems, such as Veeva Regulatory Vault.
• Sharing Subject Matter Expertise in Regulatory Information Management Systems and Processes in-use within Global Regulatory Affairs, requiring a deep understanding of the Regulatory Vault data model and legacy RIM systems
• Creation and maintenance of Regulatory Information within the company's Regulatory Information Management (RIM) system with information provided 'on demand' by end users for all GRA Submission activities - typically supporting urgent 'timebound' requests.
• Accurate completion of more complex or non-routine data maintenance tasks to an agreed schedule
• Provision of primary support to end users of RIM systems and processes to enable efficient ways of working including: provide basic guidance, adhoc training, attendance at group meetings, provision of appropriate Reports etc.
• Monitoring data quality routinely to identify and mitigate issues. Additionally, conducting root cause analysis and trend analysis to identify appropriate corrective/preventative actions
• Ensure own work and that of junior colleagues is compliant with data standards and defined procedures
• Routine/ ad-hoc extraction and transformation of raw data from various Regulatory Information Management (RIM) systems for KPI generation in the context of data quality improvement and performance monitoring
• Provision of support for system validation activities such as User Acceptance Testing, with a foundational understanding of the requirements of the Change Control procedures for enabling full impact assessment of any system/process change.
• Responsible for establishing & maintaining appropriate procedural documentation where needed: SOP, WI, How to Guide, User Manuals and Handbooks
• Ensuring continuous improvement (process & system) culture within the team for the benefit of GRA. Ensure understanding of upcoming system changes, propose changes and support the implementation of those changes within RIM.
• Where applicable, perform the role of BD Subject Matter Expert, driving a partnership with GRA Process Leads, developing deep understanding of GRA E2E business process, sharing technical expertise to support the business and continuous improvement.
• Ensuring appropriate procedures are followed in the maintenance of System Reference Data

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree in the (science preferred)
• 2+ years of previous experience regulatory experience
• Experience in a regulatory management system (RIM)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Fluent in English (written and oral)
• Fluent in English (written and oral)
• Good understanding of the role and responsibility of Registration Information Management
• Awareness of standard submission formats, with ability to navigate submission content
• Awareness of relevant health authority regulations and guidance, technology trends, as well as industry standards concerning record keeping practices, document/information management and HA submission requirements.
• Knowledge of records retention procedures and relevant regulations and business practices regarding regulatory document management
• Analytical capability; ability to work with large and varied datasets
• Good interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary, global, and matrix environment.
• Familiarity with GSK organization and processes associated with gaining and maintaining marketed and investigational product authorizations
• Excellent organizational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
• Excellent written and verbal communication skills and ability to present information in a clear and concise manner
• Demonstrated knowledge of GSK Marketed Products and development products. Awareness of drug development process
• Organization, prioritization and coordination skills
• Demonstrated proficiency in use of standard IT tools
• Familiarity with GSK IT systems in general and RIM tools, plus awareness of system validation methodology

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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